Accessibility Statement Skip Navigation
  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing
  • Login
  • GDPR
  • Create a Free Account
Return to PRWeb homepage
  • News
  • Resources
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
  • Business & Money
      • Auto & Transportation

      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Hamburger menu
  • Cision PRWeb provides efficient communication tools to continuously engage with target audiences across multiple online channels
  • Create a Free Account
    • ALL CONTACT INFO
    • Contact Us


      11AM ET Sunday – 8PM ET Friday

  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR

FDAnews Announces: Conducting Internal GMP/QSR/GCP/GLP Investigations Workshop, April 22-23, 2015
  • USA - English


News provided by

FDANEWS

Feb 20, 2015, 15:00 ET

Share this article

Share toX

Share this article

Share toX

FDAnews
FDAnews

Falls Church, VA (PRWEB) February 20, 2015 -- Conducting Internal GMP/QSR/GCP/GLP Investigations:
How to Avoid Sleepless Nights, Irreparable Harm to Your Company’s Reputation, and Massive Civil and Criminal Liability
**Presented by FDAnews and Alston & Bird LLC **
April 22-23, 2015 – Washington, DC
http://www.fdanews.com/ConductingInternalInvestigations

Don’t think a GMP/QSR/GCP/GLP whistleblower could bring a manufacturer down? Think again. One recent case resulted in penalties totaling $846 million. Here’s how to protect a drug or device manufacturing, laboratory or clinical operation.

Come to Washington for a two-day crash course in how to conduct internal investigations related to possible GMP, QSR, GCP or GLP data integrity and whistleblower related violations. Attendees will come home toting a bagful of tricks and tips to improve internal processes, strengthen compliance systems and avoid lawsuits.

Taught by three accomplished clinical, manufacturing, laboratory and white-collar crime attorneys — who have more than 50 years of experience conducting investigations, this event is like no other on the market. Get ready to discover:

How to assess initial allegation(s)

While each investigation is unique, attendees will learn guidelines that help them respond swiftly and appropriately to whistleblower complaints.

Practical and actionable first steps

• Identifying scope and purpose of the investigation
• Structuring the investigative team of internal employees, outside counsel and subject-matter experts
• Maintaining credibility of the investigation and protecting attorney-client privilege
• Best practices in document preservation and review, done cost-effectively but ready to withstand regulators’ tightest scrutiny
• Tips on interviewing employees drawn from 50 years of collective experience and hundreds of actual interviews

The ‘Park Doctrine’

Prosecutions under the so-called “Park Doctrine” are a growing threat. The “Park Doctrine” mirrors a recent Justice Dept. policy shift to changing corporate misbehavior by holding officers and employees individually accountable.

Changing corporate culture

Attendees will learn all about the “responsible corporate officer,” how one can be held liable for violations of the FDCA with no criminal intent, and how to avoid such prosecutions by cultivating a corporate culture that puts quality first.

Homeward bound

As the workshop winds up, attendees will come away with a deepened understanding of how to conduct internal investigations, plus mitigation strategies to avoid the sort of GMP/QSR/GCP/GLP that have cost others millions of dollars in civil — and criminal — penalties.

Course materials include:

• Copies of all presentations
• Current FDA regulations (full text unedited)
• Tips on conducting internal investigations
• Guidances
• Case studies
• Checklists
• Sample litigation hold/preservation notice
• Employee and witness interviewing do’s and don’ts
• Article: “Recurring Issues in Internal Investigations”
• Article: “How the Justice Dept. Consumer Protection Branch Conducts Criminal Investigations of the FDCA”
• Article: “How the Justice Dept. Uses the ‘Park Doctrine’ to Hold Officers, Managers and Employees Criminally Liable for Violations of the FDCA – No Criminal Intent Required”

Meet the Instructors:

Cathy Burgess is a partner in Alston & Bird’s Health Care Group focusing on FDA matters. Ms. Burgess advises clients on matters affecting Rx and OTC drugs, biologics, medical devices, foods and cosmetics, working with clients to spot legal risks throughout product life cycles. With her cGMP expertise, she focuses on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls, and responses to Forms 483 and Warning Letters. She also conducts internal investigations and special audits related to FDA compliance, and helps clients design compliance programs, internal audit programs and other risk mitigation strategies.

Edward (Ted) Kang is a partner in Alston & Bird’s Government & Internal Investigations Group. He focuses on white collar matters in the areas of health care, anti-corruption, Office of Foreign Assets Control (OFAC) sanctions, anti-money laundering, and the Foreign Corrupt Practices Act (FCPA). Clients include parties under investigation by the Justice Dept. and other federal and state enforcement agencies.

Mark Calloway, is a partner and immediate past leader of Alston & Bird’s Government & Internal Investigations Group, specializes in white collar criminal defense with an emphasis on health care, internal corporate investigations, compliance program development, implementation and auditing.

Conference Details
Conducting Internal GMP/QSR/GCP/GLP Investigations:
How to Avoid Sleepless Nights, Irreparable Harm to Your Company’s Reputation, and Massive Civil and Criminal Liability
**Presented by FDAnews and Alston & Bird LLC **
April 22-23, 2015 – Washington, DC
http://www.fdanews.com/ConductingInternalInvestigations

Tuition: $1,897

Easy Ways to Register
Online: http://www.fdanews.com/ConductingInternalInvestigations
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]

Modal title

Conducting Internal cGMP Investigation
View PDF
Conducting Internal cGMP Investigation
Conducting Internal cGMP Investigation
View PDF
Conducting Internal cGMP Investigation
Conducting Internal cGMP Investigation Conducting Internal cGMP Investigation

Contact PRWeb

  • 11AM ET Sunday – 8PM ET Friday
  • Contact Us

About PRWeb

  • About PRWeb
  • Partners
  • Partnership Programs
  • Editorial Guidelines
  • Resources

Why PRWeb

  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing

Accounts

  • Create a Free Account
  • Log in
  • Contact Us

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Legal
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 Cision US Inc.